TENURE4G— 510(k) K140537

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K140537 for TENURE4G, Substantially Equivalent on 2014-08-20. Applicant: Den-Mat Holdings, LLC. Device class: 2.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2014-03-04
Decision date: 2014-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lompoc, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.